I gave a talk yesterday to a great crowd at the annual UCSF CME conference, Diabetes Update. The slides from my presentation, “The Future of Diabetes Management: Social Networking and New Technologies,” can be viewed on Slideshare.
The Swedish Obese Subjects study is a fabulous example of how very-useful practical knowledge can come out of a well-conducted cohort study. Not everything has to be a prospective randomized controlled trial! This study has produced a number of landmark papers which provide convincing evidence that:
1. Bariatric surgery offers survival benefit over the long term for the morbidly obese, despite the up-front mortality risk from the surgery itself.
2. Bariatric surgery reduces cardiovascular and cancer deaths
3. Bariatric surgery is durable: most patients do not regain the weight back
4. Not all bariatric procedures are the same. Some work better than others.
5. Diets, behavioral modification, and “professional” weight loss coaching doesn’t really work for the morbidly obese in the long haul.
6. And now….bariatric surgery prevents onset of diabetes!
The strength of the Swedish Obese Subjects trial is in the follow-up. Since Sweden has a nationalized health care system, follow-up was completed on >95% of the initial cohort. Such a trial could never be conducted in the United States….our people change jobs, towns, or insurances just way too often!
And there is just one more thing you should know about the Swedish Obese Subjects trial: the vast majority of the surgery cohort underwent vertical banded gastroplasty (VBG). What’s that, you ask? It was a first-generation bariatric operation that has been abandoned worldwide in favor of better (i.e. more effective) operations, such as gastric bypass and sleeve gastrectomy. So if this trial were repeated in 2012, we would expect even better results in the surgical arm with fewer complications.
So where does that leave us? For any patient with BMI > 40 (or BMI >35 with metabolic disease), you should really get them thinking about surgery as an option. It’s not just about weight, and certainly has nothing to do with cosmetic appearance. It’s about getting serious about treating metabolic disease: diabetes, hypertension, sleep apnea, hypercholesterolemia, PCOS, and others. It’s about making sure that those diseases never develop in the first place. It’s about reducing overall cancer risk, stroke risk, and heart attack risk. And it’s about improving overall quality and quantity of life.
So why, then, with such powerful clinical evidence, do less than 1% of adults who would benefit from bariatric surgery actually get it? That, my friend, is complicated, and probably worth another blog in its own right!
Jonathan Carter, MD
I’ve previously written here about the 2 major New England Journal trials looking at treating type 2 diabetes with bariatric surgery. Those studies showed a very robust ability of bariatric surgery to treat type 2 diabetes. If you can use bariatric surgery to treat type 2 diabetes, what about prevention? This question was examined in a more recent NEJM publication of selected results from the Swedish Obese Subjects (SoS) study from Carlsson et al.
Guest Post by Dr. Jonathan Carter
I’m pleased to say that my friend and colleague, Dr. Jonathan Carter, has agreed to follow this post with a guest blog post of his own, giving his analysis of the study. Dr. Carter is an Assistant Professor of Surgery at UCSF, frequently performing bariatric surgery.
For those who skim blogs…
I’ll start with my take-away points, and then go backwards to analyze the study in more depth. So, without further ado, the major takeaways from this study are:
2) This study did not address the most important comparison, i.e. between bariatric surgery and an intensive lifestyle modification program. Unfortunately, the control group in this study received minimal attempt at lifestyle modification. Prior studies like the Diabetes Prevention Program, the Finnish Diabetes Prevention Study, and the Chinese Diabetes Prevention Study showed between a 30-50% reduction in type 2 diabetes incidence with lifestyle modification. However, one cannot directly compare the rates in these studies to each other.
3) Due to #s 1 and 2 above, the next study should directly compare bariatric surgery and intensive lifestyle modification with regard to diabetes prevention.
4) Weight loss prevents the onset of type 2 diabetes in obese patients. Bariatric surgery causes weight loss.
With these results, we have to start discussing whether it is ethical, reasonable, and cost-effective to use bariatric surgery to prevent type 2 diabetes.
Now, for those of you interested in some more information about the study and results, keep reading…
This study was a prospective, non-randomized trial which enrolled 4,047 obese patients from 1987-2001 in Sweden. The researchers note that they did not randomize the participants due to “ethical reasons related to the high postoperative mortality associated with bariatric surgery in the 1980s.” In other words, enough people died from bariatric surgery at the time the study began that it would have been unethical for them to randomly assign people to have it done.
The control group was selected by a matching algorithm that concurrently tried to keep the current mean values of the matching variables between the two groups as similar as possible. Included patients were aged 37-60 years old and had BMI over 34 for men and over 38 for women. And, of course, they did not have diabetes at baseline. Ultimately, those included in this analysis were 1,658 patients who had surgery and 1,771 who were in the control group.
Baseline characteristics: Surgery group had more severe risk factors
Due to the matching process, those in the surgery group were older, heavier (120 kg vs 114 kg), had higher insulin levels, higher blood pressures, worse cholesterol, higher smoking rates, lower physical activity rates, and higher caloric intakes compared to those in the control group. Because the groups were non-randomized, it was likely that these “sicker” and “riskier” patients were more likely to be recommended surgery by their physicians. However, in the end, this makes the results even more impressive because the surgical group had 80% lower rates of diabetes despite being a sicker group to begin with. The surgical group had the decks stacked against them, and still came out ahead. It is as if the surgical group started a 100 meter race with a 1-2 second handicap, but was still able to win.
No attempt at standardizing lifestyle therapy in control group
As I discussed above, a weakness of this study is that there was no attempt to standardize treatments in the control group. Some might say that this is a positive because it reflects “real-world” treatments. And indeed, the authors note that “patients in the control group received the customary treatment for obesity at their primary health care centers.” However, according to questionnaires, this meant that only 54% of these patients received even some professional guidance. So, nearly half of the control group received no help at all from their healthcare providers with weight loss.
The Results: Surgery caused weight loss and prevented diabetes
These two figures say it all… compared to “customary treatment” in this cohort of obese patients, the patients who got bariatric surgery lost significantly more weight (Figure S3) and had significantly less progression to type 2 diabetes (Figure 1A).
Nearly every day in my practice, a patient with diabetes asks me whether he or she should switch from multiple daily insulin injections to an insulin pump. I often have a discussion with patients about whether or not they should be using a CGM (continuous glucose monitor) to help monitor blood glucose instead of just using SMBG (self-monitoring of blood glucose). As an endocrinologist, it is very important to be able to advise patients about specifically what these new technologies have to offer them. Do they decrease mortality? Do they decrease long-term diabetes complications? Do they improve glycemic control? Do they improve quality of life for patients? Do they lower costs? All new medical technologies need to undergo a rigorous evaluation and testing with these types of questions in mind. This is critical not just so that I can be honest and helpful to my patients, but also from the overall perspective of the healthcare system.
In that vein, Yeh et al recently published a meta-analysis in the Annals of Internal Medicine called “Comparative Effectiveness and Safety of Methods of Insulin Delivery and Glucose Monitoring for Diabetes Mellitus: A Systematic Review and Meta-analysis.”
This meta-analysis, funded by AHRQ, looked at the differences between:
- MDI vs CSII (multiple daily injections vs continuous subcutaneous insulin infusion)
- Type 1 vs type 2 diabetes
- SMBG (self-monitoring of blood glucose) vs rt-CGM (real-time continuous glucose monitoring)
What types of studies did they include in their meta-analysis?
- Studies of adults, adolescents, or children with type 1 or type 2 diabetes mellitus
- Studies from 1966-2012
- 19 studies comparing CSII with MDI (>3 injections per day of either basal/bolus insulin or NPH/regular)
- 10 studies comparing CGM with SMBG (>3 fingersticks per day)
- 4 studies comparing SAP (Sensor-augmented pump) use with MDI + SMBG
* Studies were excluded if regular insulin was used in the CSII (pump) group (they felt this to be a weakness of prior analyses)
Here is the key data table:
A few things pop out from this table:
- Overall, they assessed the strength of evidence as relatively weak.
- In children and adolescents, CSII showed no difference in clinical outcomes from MDI. CSII was better in terms of quality-of-life.
- In adults with type 1 diabetes, CSII led to more symptomatic hypoglycemia, but better hemoglobin A1c and quality-of-life.
- There were no differences between CSII and MDI in adults with type 2 diabetes.
- CGM, whether with an insulin pump or not, led to a benefit in glycemic control without any difference in hypoglycemia.
Some concerns and words of caution when interpreting these results:
- Meta analyses can always suffer from publication bias. That is, studies are much more likely to be published if they show positive results. So it is possible that studies have been done that generated results that would have shown no difference between the two methods being studied, but these may never have been published and thus cannot be included in the meta-analysis.
- These studies all had durations of 12-52 weeks. There were no studies reporting on long-term outcomes like micro or macrovascular disease.
- 24 of the articles (approximately 2/3) were supported by pharmaceutical companies
What does this mean?
According to this meta-analysis, CGMs did improve glycemic control. Insulin pumps did not appear to have a significant effect on clinical outcomes, but did positively effect quality of life. Remember that the studies included were all between 12 and 52 weeks, so one major limitation is that any longer-term effects would not be teased out.
While some may discount the quality of life improvements seen with the pump as being less important than clinical outcomes, I caution people from doing so. In a condition as omnipresent as diabetes, maintaining good quality of life for the patient is critical and a very important goal.
In the end, the decision about whether or not to use one of these devices comes down to a conversation with the patient and their family, based on their personal preferences and what each device might offer them in terms of benefits and harms. This meta-analysis adds some more information to that conversation.
Finally, this meta-analysis shows that we simply need more data to study so that more concrete conclusions can be drawn.
From the always on-point and eloquent Dr. Bryan Vartabedian at Baylor and his blog 33charts, “The case for new physician literacies in the digital age.”
And from Cooper.com, “The best interface is no interface.”
I’ll admit that I’ve not yet read this journal article to form my own conclusions, but I found the headline interesting nonetheless. Here is a link to the NY Times article and a link to the original journal article in the Journal of Academic Medicine. It makes intuitive sense… if your physician has a higher level of empathy, you are more likely to form a positive treatment relationship, and the patient is thus more likely to find meaningful and useful treatment recommendations from that relationship, and will end up with fewer acute metabolic complications. Definitely adding this paper to my journal article reading list.
Does this sound like something that has happened to you? You are driving, you stop at a red light, and all of a sudden you find that your iPhone has migrated its way from your pocket or the passenger seat of the car into your hands. You push an elevator button and pull the phone out of your pocket to glance at it in that split second while waiting for the door to open. You eat dinner with a group of six friends and everyone is buried in Facebook rather than making eye contact. In all facets of life, we are quickly becoming more entangled with our machines, allowing them to become extensions of ourselves. The hallowed walls of the doctor’s office have not shielded out this rising tide. This “Piece of my Mind” by Elizabeth Toll in the June 20th JAMA eloquently captures what so many of us have been feeling and seeing over the last few months and years. Here is an excerpt of her opening paragraph and the drawing she discusses:
Dr. Toll goes on to discuss how this particular physician is someone overflowing with empathy for patients and enthusiasm for medicine. Unfortunately, the computer has now demanded his attention, which he can no longer fully devote to his patient. I agree wholeheartedly with Dr. Toll and I hope that her article will spark a dialogue about this issue in the medical community.
Part of the problem is the current generation of electronic health record (EHR) systems. They demand too much cognitive effort to use. In fact, Horsky et al showed that users of a CPOE system used twice as much cognitive effort on system operation as on patient-centered clinical reasoning. This balance has to shift. Nobody wants her physician wasting his energy and focus like this.
This improvement in EHRs will happen. As was pointed out on Twitter this morning by
@ReasObBob: “ #EHRs will get better. Poor EHRs are not the problem but the symptom. New approach needed. We’re working on it.” Bob is right. The current generation of EHRs has been built to meet the demands of a healthcare system that is focused on compliance and billing. We got what we asked for. This time around, let’s ask for what we really want. Let’s ask for EHRs that are sleek and streamlined, easy to use, and that augment the high-quality and high-empathy medical care we want to provide.
What are physicians to do in the meantime? I have spent some time in the last few years thinking and reading about this. How can we best maintain the doctor-patient relationship in the age of the EHR? I offer you seven tips:
1) Set-up your office properly, with placement of the chairs, monitor, and keyboard to best support good eye contact between you and the patient. Don’t allow your office to become like this drawing, where your chair could put your back to the patient. This is common sense, not Feng Shui. (I will post some photos of exam rooms at the bottom of this blog piece to allow you to start to think about what works and what does not work)
2) Get a quiet keyboard. If you think this sounds trivial, try this: Spend one day in your clinic using a loud keyboard and then switch to a quiet one. You’ll see.
3) If you can, spend thirty seconds preparing the electronic visit before you walk in to see the patient so that you are ready to hit the ground running. You want to be immediately ready to let a patient start talking to you without interruption to start the visit. Visits get off to a bad start when they go like this: “So, what brought you in here?” “Well, my thyroid…” “Hold on a minute, I have to log-on and get a new progress note open so I can write down what you say.”
4) Let the patient see your screen. Hopefully you are not reading ESPN.com when you are talking to your patient. Let them share the experience with you, and share the fact that you are populating their medical record. I have on many occasions had this lead to bonding moments with my patients when we are both hunting through the CPOE (computerized provider order entry) system for a particular type of glucose test strip prescription or some other seemingly hidden or obscure task.
5) For part of your visit with the patient, stop typing, take your hands away from the mouse and keyboard, and use the body language we learned how to use as first year medical students in Introduction to Clinical Medicine. Every visit has at least one natural moment when the patient has to be certain that one-hundred percent of your attention is focused on her.
6) Practice. Seeing patients while using an EHR is a learned skill. None of us were able to handwrite a perfect note while talking to a patient the first day of medical school. The new generation of medical students will learn how to talk to patients while typing from day one. At UCSF, the new Kanbar Teaching and Learning Center has simulated exam rooms to help medical students learn this (although, embarrassingly, you’ll notice in the photos on their website that the computer monitors are buried in the corner of each exam room, assuring the “back-to-patient” syndrome).
7) Remember that this is our chance to take back the medical record. Let us not forget that, even with paper charts, the medical chart has increasingly become about legal protection, billing, and reimbursement. The EHR gives us a clean slate, a new opportunity that brings us legible notes and notes that are immediately visible to colleagues. Take advantage of this. Write good narratives. Tell your patients’ stories. Make the medical record useful again.
Sample photos of exam rooms
(Note: This was originally a guest-post on the blog of my friend and colleague, Dr. Russ Cucina, at http://russcucina.wordpress.com/ and is re-blogged here for my readers)